Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201402000725372 Date of Approval: 16/12/2013
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Evaluating Handheld Clinical Decision Support Tools to Improve Community-Based Delivery of Reproductive and Pediatric Health Services
Official scientific title Evaluating Handheld Clinical Decision Support Tools to Improve Community-Based Delivery of Reproductive and Pediatric Health Services
Brief summary describing the background and objectives of the trial Description from IRB proposal: We will test the null hypothesis that the proportion of mothers receiving a postnatal check-up within 48 hours of delivery is no different among Community Health Workers (CHWs) with access to Clinical Decision Support (CDS) software compared to those without the software. In addition, we will test secondary hypotheses that a mobile phone platform is a cost-effective alternative to paper-based data collection and that it is an acceptable method of data collection and dissemination in the community. The primary aim will be to evaluate the effectiveness, costs and acceptability of a handheld CDS Smart Forms system for improving the delivery of community-based maternal and child health services. Specifically, we will accomplish four objectives: 1. Evaluate comparatively the effectiveness of CDS ¿Smart Forms¿ to increase the proportion of mothers receiving a postnatal check-up by a Community Health Worker within 48 hours of delivery; 2. Evaluate the effectiveness of incorporating patient-specific multimedia Information, Education and Communication (IEC) materials into Smart Forms for increasing ANC visits, immunizations, use of ITNs, facility-based deliveries, exclusive breastfeeding and other behavior changes among pregnant women and new mothers; 3. Determine the cost-effectiveness of CDS Smart Forms employed by CHWs from the societal and Ministry of Health perspectives over a lifetime time horizon; 4. Assess qualitatively the process of implementation of the Smart Forms system, including the technical specifications, human capacity requirements, and acceptability among patients and providers.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Pregnancy and Childbirth,Reproductive and paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 15/07/2013
Actual trial start date 15/07/2012
Anticipated date of last follow up 15/01/2014
Actual Last follow-up date
Anticipated target sample size (number of participants) 600
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Using a truly random number generated by random.org This was a health services implementation that was impossible fully to blind. Open-label(Masking Not Used)
Parallel: different groups receive different interventions at same time during study Randomised Using a truly random number generated by random.org This was a health services implementation that was impossible fully to blind. Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Clinical Decision Support Continuous availability of CDS tool Continuous availability of CDS tool Use of clinical decision support tool on Android device 300
Control Group Android Phone lacking CDS tool No access to CDS No access to CDS Use of Android phone for data collection and information dissemination 300 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- In terms of clusters, all CHWs that work in the Kosirai Division of the Ministry of Health Community Services and work together with the AMPATH Primary Health Care initiative will be eligible - In terms of measured outcomes, all pregnant women who are provided home-based services by the CHWs in the Kosirai division will be eligible - In terms of the clusters, all individuals who are not Community Health Worker in Kosirai are excluded - In terms of measured outcomes, men, women who are not pregnant, and children who are not delivered during the study will be excluded 0 Year(s) 99 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 09/08/2011 Moi University, Moi Teaching and Referral Institutional Research and Ethics Committee (IREC)
Ethics Committee Address
Street address City Postal code Country
PO Box 3 Eldoret 30100 Kenya
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 20/09/2011 Yale University Human Investigations Committee (HIC)
Ethics Committee Address
Street address City Postal code Country
55 College St New Haven 06510 United States of America
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 22/02/2012 University of Toronto Health Sciences Research Ethics Board
Ethics Committee Address
Street address City Postal code Country
12 Queens Park Crescent West, 2nd Floor Toronto M5S 1S8 Canada
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Proportion of pregnant women visited within 48 hours of delivery The outcome will be collected continuously and entered into the patient's electronic medical record. However, the outcome will only be measured at the final conclusion of the study in a retrospective review via the AMPATH electronic medical recored system, AMRS.
Secondary Outcome Percentage of Pregnant women visited in third trimester The outcome will be collected continuously and entered into the patient's electronic medical record. However, the outcome will only be measured at the final conclusion of the study in a retrospective review via the AMPATH electronic medical recored system, AMRS.
Secondary Outcome Perent of deliveries conducted by a skilled birth attendant The outcome will be collected continuously and entered into the patient's electronic medical record. However, the outcome will only be measured at the final conclusion of the study in a retrospective review via the AMPATH electronic medical recored system, AMRS.
Secondary Outcome Percent of women attending 4 ANC visits The outcome will be collected continuously and entered into the patient's electronic medical record. However, the outcome will only be measured at the final conclusion of the study in a retrospective review via the AMPATH electronic medical recored system, AMRS.
Secondary Outcome Median Number of ANC Visits The outcome will be collected continuously and entered into the patient's electronic medical record. However, the outcome will only be measured at the final conclusion of the study in a retrospective review via the AMPATH electronic medical recored system, AMRS.
Secondary Outcome Percent of HIV+ pregnant women receiving preventive ARVs The outcome will be collected continuously and entered into the patient's electronic medical record. However, the outcome will only be measured at the final conclusion of the study in a retrospective review via the AMPATH electronic medical recored system, AMRS.
Secondary Outcome Percent of pregnant women receiving IPT, Percent sleeping under ITN The outcome will be collected continuously and entered into the patient's electronic medical record. However, the outcome will only be measured at the final conclusion of the study in a retrospective review via the AMPATH electronic medical recored system, AMRS.
Secondary Outcome Percent of neonates receiving BCG at birth, Percent receiving OPV at birth The outcome will be collected continuously and entered into the patient's electronic medical record. However, the outcome will only be measured at the final conclusion of the study in a retrospective review via the AMPATH electronic medical recored system, AMRS.
Secondary Outcome % neonatal deaths (<1 month), percent of early neonatal deaths (<1 week), percent of maternal deaths The outcome will be collected continuously and entered into the patient's electronic medical record. However, the outcome will only be measured at the final conclusion of the study in a retrospective review via the AMPATH electronic medical recored system, AMRS.
Secondary Outcome Postnatal behavior: Percent of Women initiating FP, percent exclusively breastfeeding, percent of children sleeping under and ITN The outcome will be collected continuously and entered into the patient's electronic medical record. However, the outcome will only be measured at the final conclusion of the study in a retrospective review via the AMPATH electronic medical recored system, AMRS.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
AMPATH (AMRS) PO Box 5760 Eldoret 30100 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Yale University NIH Medical Scientist Training Grant (NIH MSTP TG 2T32GM07205) 367 Cedar Street, Room 316 ESH New Haven, CT 06511 United States of America
Grand Challenges Canada 101 College St, Suite 406 Toronto, ON M5G 1L7 Canada
Yale University Drazan Fellowship 47 College Street, Suite 108 New Haven, CT 06520-8034 United States of America
Gillian and Adrian Schauer Foundation Toronto, ON Canada
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Moi Teaching and Referral Hospital PO Box 3 Eldoret 30100 Kenya Hospital
COLLABORATORS
Name Street address City Postal code Country
Yale University School of Public Health 47 College Street New Haven, CT 06520 United States of America
University of Toronto 509-155 College Street Toronto, ON M5T 3M7 Canada
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Astrid Christoffersen-Deb astridcdeb@gmail.com 0728908167 PO Box 5760-30100
City Postal code Country Position/Affiliation
Eldoret 30100 Kenya Co-Field Director, AMPATH Reproductive Health
Role Name Email Phone Street address
Public Enquiries Louis Fazen louis.fazen@yale.edu 0705148134 PO Box 5760-30100
City Postal code Country Position/Affiliation
Eldoret 30100 Kenya Yale University School of Public Health, Graduate Student
Role Name Email Phone Street address
Scientific Enquiries Louis Fazen Louis.Fazen@yale.edu 0705148134 PO Box 5760-30100
City Postal code Country Position/Affiliation
Eldoret 30100 Kenya Yale University School of Public Health, Graduate Student
REPORTING
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